UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019381 |
|---|---|
| Receipt number | R000022409 |
| Scientific Title | The association analysis between genome modification and physical changes by environmental conditions |
| Date of disclosure of the study information | 2015/10/18 |
| Last modified on | 2023/10/23 10:58:53 |
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Basic information
Public title
The association analysis between genome modification and physical changes by environmental conditions
Acronym
The association analysis between genome modification and physical changes by environmental conditions
Scientific Title
The association analysis between genome modification and physical changes by environmental conditions
Scientific Title:Acronym
The association analysis between genome modification and physical changes by environmental conditions
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the relationship between genomic and epigenomic changes and physical conditions.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between genomic and epigenomic changes and physical conditions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The methylation of DNA in promoter regions of human genome
WBC, RBC, Hb, Ht, Plt, TG, HDL-Cho, LDL-Cho, AST, ALT, gamma-GTP, BUN, Serum Cr, UA, fasting blood glucose, HbA1c
Key secondary outcomes
Height, Body weight, BMI, Boby fat percentage, systolic blood pressure, diastolic blood pressure, Pulse rate, Active mass
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Volunteers who participated in the clinical trials carried out in the our research center
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1. Subjects who received dietary advice due to disease.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities
3.Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with serious anemia
5. Subjects who are at risk of having allergic reactions to drugs or foods
6. Subjects regularly take medicine
7. Subjects who donate whole blood within 4 weeks or blood components within 2 weeks prior to this study.
8. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial
9. Any other medical reasons judged by the the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | NISHIHIRA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | NISHIHIRA |
Organization
Hokkaido Information University
Division name
Center of Health Information Science
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Northern Advancement Center for Science & Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 24 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 09 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 28 | Day |
Other
Other related information
During trail region, it investigates whether the methylation of DNA changes even if there is no change in eating habits.
It investigates the association between physical conditions and the methylation of DNA.
Management information
Registered date
| 2015 | Year | 10 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022409
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
